PAIN RELIEF GEL-ROLL ON- menthol gel

PAIN RELIEF Gel-Roll On by

Drug Labeling and Warnings

PAIN RELIEF Gel-Roll On by is a Otc medication manufactured, distributed, or labeled by Shanghai Chuangshi Medical Technology (Group) Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Menthol 4.0% w/w ...... Purpose: Topical Analgesic

Purpose

Topical Analgesic

Uses

Temporary relief from minor aches and pains of sore muscles and joints associated with arthritis, backache, strains and sprains

Warnings

For external use only

Flammable

Keep away from excessive heat or open flame

Ask a doctor before use if you have

Sensitive skin

When using this product

Avoid contact with eyes or mucous membranes Do not apply to wounds or damaged skin Do not use with other ointments, creams, sprays or liniments Do not apply to irritated skin or if excessive irritation develops Do not bandage Wash hands after use with cool water Do not use with heating pad or device Store in a cool dry place

DO NOT USE

Do not apply to wounds or damaged skin Do not use with other ointments, creams, sprays or liniments Do not apply to irritated skin or if excessive irritation develops Do not bandage Do not use with heating pad or device

Stop use and ask a doctor if

Condition worsens or if symptoms persist for more than 7 days, or clear up and reoccur

If pregnant or breast-feeding

Ask a health professional before use

Keep out of reach of children

If accidentally ingested, get medical help or contact a Poison Control Center immediately

Directions

Adults and children 12 years of age and older:

Rub a thin film over affected areas not more than 4 times daily; message not necessary

Children under 12 years of age: Consult physician

Inactive Ingredients

Alcohol, Aloe Barbadensis Leaf Extract, Arnica Montana Flower Extract, Boswellia Carterii Resin Extract, Camellia Sinensis Leaf Extract, Carbomer, Camphor, FD&C Blue 1, FD&C Yellow 5, Glycerin, Ilex Paraguariensis Leaf Extract, Isopropyl Myristate, Silica, Triethanolamine, Vitamin E, Water

Questions or Comments

86-21-31166566

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PAIN RELIEF GEL-ROLL ON 
menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73557-333
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	0.04 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL 95% (UNII: 7528N5H79B)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
.ALPHA.-TOCOPHEROL, D- (UNII: N9PR3490H9)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
GLYCERIN (UNII: PDC6A3C0OX)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
FRANKINCENSE (UNII: R9XLF1R1WM)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73557-333-25	74 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/28/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	12/28/2022

Labeler - Shanghai Chuangshi Medical Technology (Group) Co., Ltd. (546872672)

Registrant - Shanghai Chuangshi Medical Technology (Group) Co., Ltd. (546872672)

Establishment
Name	Address	ID/FEI	Business Operations
Shanghai Chuangshi Medical Technology (Group) Co., Ltd.		546872672	manufacture(73557-333) , label(73557-333)